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The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls

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ClinicalTrials.gov Identifier: NCT03628937
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
In this study, 7-10 years old obese girls will be recruited to test the preventive effect of decaffeinated green tea polyphenols on the risk of precocious puberty by the random, placebo-control and single blind design. The intervention group will be given decaffeinated green tea polyphenols capsule (400mg/d) and the control group will be given placebo. The oral treatment will be lasted for 12 weeks.Then all the subjects will be followed up every 3 months until three months after menstruation. At the baseline and after the 12 week intervention, the clinical manifestations of secondary sexual characters, the serum levels of sex hormones will be determined as the outcome variables. After controlling confounding factors, the preventive effect of the green tea polyphenols on precocious puberty or early puberty among obese girls will be analyzed.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Puberty, Precocious Dietary Supplement: Decaffeinated Green Tea Polyphenol Other: Placebo control Not Applicable

Detailed Description:
Simple obese girls are prone to premature or early puberty. The topic proposed based on previous studies, recruiting of 200 simple obesity girls, aged 7 to 10 years old. After the informed consent, they will be randomly divided into intervention group and control group, intervention group will be given tea polyphenol capsule (400 mg, epigallocatechin gallate (EGCG) accounted for 50%), the control group given placebo capsule. Participants need take it once a day after breakfast. All of them will receive similar health advice on proper diet and exercise. The intervention will last 12 weeks, followed by telephone every 3 months until 3 months after menarche. The researchers will measure children obesity index (using artificial detection), youth development index (secondary sex characteristic clinical manifestations, serum sex hormone, B ultrasonic examination uterus ovarian and breast volume, etc.) in three stages: at the baseline, after 12 weeks intervention and the end of three months after menstruation. The liver and kidney function, blood and urine routine and serum trace elements will be detected before and after the three-month intervention. Through the above detection of the indicators related to obesity and sexual precocious puberty, it is explored whether the decaffeinated tea polyphenol has preventive effects on precocious puberty.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 31, 2023


Arm Intervention/treatment
Experimental: Intervention group

Interventions: Decaffeinated green tea polyphenol capsule (400 mg, EGCG accounted for 50%) will be given to participants in intervention group, and they need take it once a day after breakfast for 12 weeks.

Decaffeinated green tea polyphenol: 400mg/capsule, 1 capsule/d, qd, 12 weeks

Dietary Supplement: Decaffeinated Green Tea Polyphenol
Intervention group will be given decaffeinated green tea polyphenol capsules (400 mg, EGCG accounted for 50%). Participants need take it once a day after breakfast for 12 weeks.

Placebo Comparator: Control group
The placebo control group will be given placebo capsules, and participants need take it once a day after breakfast for 12 weeks.
Other: Placebo control
The starch capsule was used as a placebo control, which has the same dosage, appearance and smell compared to decaffeinated green tea polyphenol capsule. The use frequency and duration are consistent with intervention group.




Primary Outcome Measures :
  1. The incidence of Precicous Puberty in the intervention groups and the placebo group. [ Time Frame: about two years ]
    Female precocious puberty is defined as the development of secondary sexual characteristics before the age of 8 or menarche before the age of 10. In our study, after intervention, for girls under 8 years of age, we recorded their rate of secondary sexual characteristics at 8 years of age; and for girls under 10 years of age, we recorded their rate of menarche at 10 years of age. The difference in the incidence of precocious puberty between the two groups is the primary outcome.


Secondary Outcome Measures :
  1. The average age of onset of menarche in two groups [ Time Frame: an average of 4 years ]
    Record the age of the onset of menarche of each girl and comparing the average age between two groups, to explore whether green tea polyphenols could delay the early pubertal development.

  2. The change in BMI at week 12 intervention from the baseline [ Time Frame: 12 weeks ]
    Obesity is an important contributing factor to the early onset of puberty for girls. Green tea polyphenols may prevent precocious puberty by controlling body weight and reducing serum leptin level.

  3. The change of breast tissue volume at week 12 intervention from the baseline [ Time Frame: 12 weeks ]
    These indicator is important indicators related to sexual development.

  4. The change of uterus volume at week 12 intervention from the baseline [ Time Frame: 12 weeks ]
    These indicator is important indicators related to sexual development.

  5. The change of the number of follicles with diameter of > 4mm follicles in ovary at week 12 intervention from the baseline [ Time Frame: 12 weeks ]
    These indicator is important indicators related to sexual development.

  6. The change of serum sex hormone levels at week 12 intervention from the baseline [ Time Frame: 12 weeks ]
    These indicators are important indicators related to sexual development.

  7. The status of liver and kidney function at the baseline and after 12 weeks intervention [ Time Frame: 12 weeks ]
    To indentify the safety of green tea polyphenol intake for obesegirls



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Ages Eligible for Study:   7 Years to 10 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 7-10 years old;
  2. BMI reached or exceeded the obesity threshold of school-aged girls in China (7 years old, BMI>=18.9; 8 years old, BMI>=19.9;9 years old, BMI>=21.0; Age of 10, BMI>=22.1);
  3. having not received sex hormone drugs, gonadotropin-releasing hormone (GnRH) drugs and Chinese medicine for the prevention and treatment of precocious puberty in the past;
  4. the guardian's informed consent;

Exclusion Criteria:

  1. secondary obesity (such as hormone therapy);
  2. weight loss treatment is currently under way;
  3. menarche or central precocious puberty has been clearly diagnosed;
  4. patients with serious heart, liver, kidney, hematopoietic system diseases and endocrine genetic metabolic diseases;
  5. iron therapy is under way;
  6. patients with acute and chronic inflammation;
  7. other conditions that the researchers believe may influence the observation results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628937


Contacts
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Contact: Xiuhua Shen, Professor +86-139-169-10428 srachel@126.com
Contact: Luyao Xie, Master +86-131-2210-9908 xlystephanie@163.com

Locations
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China, Shanghai
Department of Clinical Nutrition, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: Xiuhua Shen, Doctor    13916910428    srachel@126.com   
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Study Chair: Xiuhua Shen, Professor Xinhua Hospital Afflicated to Shanghai Jiaotong University of Medicine

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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03628937     History of Changes
Other Study ID Numbers: XH-18-009
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Green tea polyphenols
Children obesity
Precocious puberty
Prevention
Additional relevant MeSH terms:
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Pediatric Obesity
Puberty, Precocious
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Gonadal Disorders
Endocrine System Diseases